Exploratory study on Omalizumab in patients affected by Painful Bladder Syndrome - ND
- Conditions
- Painful bladder syndromeMedDRA version: 9.1Level: LLTClassification code 10011796Term: Cystitis interstitial
- Registration Number
- EUCTR2008-006559-27-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age > 18 years, weight 20-150 kg, total serological IgE 30-700 IU/mL, allergy as medical history, diagnosis of painful bladder syndrome with sympthoms present for at least 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnant of feeding women, significant clinical conditions (neoplasia, infections, emathological, renal, liver, cardiovascular, endocrine or gastrointestinal pathologies), urinary frequency < 5 urinations/day, ipersensitivity to Omalizumab ingredients including excipients, alcohol or drugs abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy of Omalizumab in the treatment of painful bladder syndrome;Secondary Objective: Not applicable;Primary end point(s): Evaluation of the efficacy of Omalizumab after 12 months treatment of painful bladder syndrome
- Secondary Outcome Measures
Name Time Method